Risk-based Quality Management Video (RBQM) Series, Part Two

While patient safety remains the primary concern of guidance ICH E6, revision 3 further directs sponsors to include patients in the research process. In part two of our RBQM video series, Amy Kissam-Sands, Senior Vice President, Clinical Operations and Tim Audin, Senior Director, Risk Management talk with Taren Grom, Editor, PharmaVOICE about how to implement a proactive risk-management approach and address patient input in study design.

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Risk-based Quality Management Video (RBQM) Series, Part Three
Risk-based Quality Management Video (RBQM) Series, Part Three

ICH Q9 (1) focuses on Quality Risk Management. Revisions may influence how we apply and perform risk manage...

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Risk-based Quality Management (RBQM) Video Series, Part One
Risk-based Quality Management (RBQM) Video Series, Part One

RBQM calls for new ways of operating that will change the clinical development process. ICH E8 (R1) will gu...